23andMe

23andMe

Since 2007, 23andMe has been selling a personal genomics test: using a kit, you submit your saliva for genetic sequencing, and receive a dataset all about your genealogy, disease risk factors, and so forth. Today, the Food and Drug Administration published a letter giving the company two weeks to discontinue marketing the kit, which the agency classifies as a medical diagnostic device in need of approval.

According to the letter, the FDA has been seeking information needed to approve the test for a while, "including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications":

months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now nine months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.